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    Celiac Vaccine Clears First Big Clinical Trial


    Jefferson Adams


    • Will a vaccine work against celiac disease?


    Image Caption: Photo: Andres Rueda

    Celiac.com 04/03/2017 - Massachusetts biotech firm ImmusanT has announced the successful completion of its first phase 1b trial of Nexvax2, an immunotherapy drug designed to protect celiac sufferers from the adverse effects of gluten exposure, including gastrointestinal symptoms, such as diarrhea, abdominal pain and bloating.


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    Nexvax2 is a drug that relies on three peptides designed to promote T cells involved in the inflammatory reaction in celiac disease to become tolerant to gluten. The company hopes that an initial course will promote gluten-tolerance, which can then be maintained by periodic boosters of the vaccine.

    The phase 1b trial in 38 patients showed no issues with safety or tolerability, and indicated that the immunotherapy seemed to work as designed.  The study also helped ImmusanT to determine dosages for phase 2 trials to determine if Nexvax2 can protect patients on a gluten-free diet from inadvertent gluten exposure, which ImmusanT sees as the quickest route to approval.

    If Nexvax2 proves to be effective in preventing accidental gluten exposure in celiac patients, the company plans a follow-up program to see if immunotherapy with Nexvax2 can eliminate the need for a gluten-free diet in celiac patients; a step that represents a daunting challenge, and is somewhat of a Holy Grail for celiac researchers.

    ImmusanT is also developing diagnostic protocols for the vaccine, which are designed to guide its use and help improve diagnosis rates.

    Nexvax2 is just the latest in a large crop of auxiliary treatments aimed at celiac disease. Switzerland's Anokion teamed up with Japanese pharma Astellas in 2015 to form Kanyos, a company working on an immunotherapy for celiac disease along with type 1 diabetes. A company called Sanofi is also working with Selecta on a similar approach.

    Meanwhile, in 2013 AbbVie licensed rights to Alvine Pharmaceuticals AVL003, an oral therapy designed to break down gluten in the GI tract before it can cause damage.

    So, stay tuned celiac sufferers, the next few years could produce some very interesting new treatments for celiac disease, something considered impossible just ten years ago.

    Source: Fierce Biotech

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    Guest Sara P

    Posted

    Krispy Kreme for a week if this becomes a reality!

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    Guest Christina Sirr

    Posted

    Sure get a vaccine that supposedly cures an autoimmune disease that was most likely caused by vaccines...makes sense if you don't mind following the big pharma religion to the grave.

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    Guest CATRYNA WHITE

    Posted

    Take Sanofi out and shoot them. Now they have developed a BS vaccine to cure an auto immune disease that was caused by vaccines, in the first place. My hope is that no one is fooled by this enormous lie. Those of us who are gluten intolerant or celiac don't need this garbage. With proper diet we are improving our health and we don't need you or your filth!

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    Guest admin

    Posted

    Take Sanofi out and shoot them. Now they have developed a BS vaccine to cure an auto immune disease that was caused by vaccines, in the first place. My hope is that no one is fooled by this enormous lie. Those of us who are gluten intolerant or celiac don't need this garbage. With proper diet we are improving our health and we don't need you or your filth!

    Vaccines do not cause autoimmune diseases, this is a fully debunked myth.

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    Guest Brent

    Posted

    Great news. Let's hope the next phase works too as being coeliac is a living hell and want to be free of worry about food and live again.

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    I've lived with celiac and Crohn's all my life and for the nay-sayers on this list, get with the program. There are so many other dangerous side-effects due to inflammation and not related to stomach-aches and frequent bathroom stops that are scary. I've managed my entire life of 62 years and believed the same thing in my younger years. One example is blood clots in my legs due to inflammation affecting my aorta causing it to throw out clots. I've never smoked or had even a single drink of alcohol my entire life and my cholesterol is great and blood pressure is almost always perfect so doctors were confused why I had arterial clotting in my leg and believe it's all related to inflammation from both Crohn's and celiac. We all need to encourage researchers to keep up the good work! I do agree that drug companies have received well deserved criticism and wish the government would see healthcare as important as gun rights!

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    Guest Robyn

    Posted

    This is AMAZING news! Having had Celiac for about 16 years now, I have been hoping and praying for something like this for SO long. I rarely look forward to events where food is being served because of the obvious. While eating gluten-free has certainly improved over the last several years, if this vaccine works, AND is safe (for those who somehow see this vaccine as a negative thing!) it will change so many lives making the almost inevitable/accidental cross contamination a thing of the past so that we can be healthier! Plus, it will make going to parties, and everything involved around food, a true joy again! Thanks for the great news and, hopefully, keep it coming!!

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    Guest Chattanooga Charlie

    Posted

    I have never see any meaningful info that vaccines cause Coeliac disease. Many vaccines do have some possible bad or no helpful outcomes for a certain set of recipients. I had to go to ER after a Flu vaccine. I have the gene that says that I am high risk for Coeliac disease. My father died from Coeliac disease. In any case, I would be very leery of anything involving autoimmunity. There are many of the new autoimmune biologics that can have very serious consequences. A very well regarded Endocrinologist along with others see Coeliac disease patients with other autoimmune disorders. I would want to know the possible bad effects before even considering such a vaccine.

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    Take Sanofi out and shoot them. Now they have developed a BS vaccine to cure an auto immune disease that was caused by vaccines, in the first place. My hope is that no one is fooled by this enormous lie. Those of us who are gluten intolerant or celiac don't need this garbage. With proper diet we are improving our health and we don't need you or your filth!

    Catryna White - Celiac disease was first identified in ancient Greece - they didn't have vaccines! Celiac health improved during World Wars due to lack of flour. If you look at the history of celiac disease and it's genetic trait you wouldn't believe such rubbish.

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    Yes, thank you! Vaccines do NOT cause autoimmune disease. I am a health care professional and I wish that more of us would speak out against this myth!

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    Guest Debbie Stevens

    Posted

    Gluten is destructive for many people. Why develop a vaccine against it? Get rid of the glyphosate soaked wheat! Get to the root cause of the problem. We need food that is healthy and nutritious, not harmful to us.

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    Guest coloradosue

    Posted

    Question: Is there a treatment that now stops the immediate reaction to gluten and also stops damage occurring to the villi? The treatments that are being tested in the article seem to be singular instead of all inclusive. And how much will these treatments cost? If the high cost of the testing device is any indication, we are looking breaking the bank just to eat "bread". I will continue to be gluten free via diet which is free. - sorry didn't mean to do any rhyming here.

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    No thanks. We don't really need bread to survive. Celiac disease has contributed to my RA, MS, Sjogren's, and OP. How would I know one vaccine would not trigger response that is not foreseen? Sometimes we guinea pigs for the drug companies. They are trying to treat the symptom, not the cause. Further down the road, we will see what this has done to people.

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    Guest JStinson

    Posted

    Sure get a vaccine that supposedly cures an autoimmune disease that was most likely caused by vaccines...makes sense if you don't mind following the big pharma religion to the grave.

    Please site the evidence that vaccines cause celiac disease.

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    Guest Jefferson Adams

    Posted

    Catryna White - Celiac disease was first identified in ancient Greece - they didn't have vaccines! Celiac health improved during World Wars due to lack of flour. If you look at the history of celiac disease and it's genetic trait you wouldn't believe such rubbish.

    Thanks for commenting!

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    Guest Jefferson Adams

    Posted

    Gluten is destructive for many people. Why develop a vaccine against it? Get rid of the glyphosate soaked wheat! Get to the root cause of the problem. We need food that is healthy and nutritious, not harmful to us.

    That story about glyphosate-soaked wheat is also a myth. There is zero actual evidence to support those claims. There is zero evidence that glyphosate causes celiac disease. Much greater chance that things like reovirus are a cause. Also, using your logic, you might just as well say: Smallpox is destructive for many people. Why develop a vaccine against it? The logic just doesn't work.

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    Guest Jefferson Adams

    Posted

    No thanks. We don't really need bread to survive. Celiac disease has contributed to my RA, MS, Sjogren's, and OP. How would I know one vaccine would not trigger response that is not foreseen? Sometimes we guinea pigs for the drug companies. They are trying to treat the symptom, not the cause. Further down the road, we will see what this has done to people.

    You do realize that one reason humans are actually alive in such large numbers is because of bread? You do realize that the vast majority of people have zero problem with wheat and bread, that they are actually part of a healthy diet for most people? Lastly, I didn't feel like a guinea pig when I got my polio vaccine. Not sure where you're coming from on this.

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    Guest Brent

    Posted

    Gluten is in much more than bread sadly. If I could just not eat wheat bread, my life would be great. Cross contamination is what makes coeliac diease so hard to live with.

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    Guest Rebecca

    Posted

    I appreciate Dan's comments. My daughter has Celiac and Hashimoto's, and while I will not rush to try any vaccine for her, I do believe that inflammation related to these autoimmune conditions is very destructive to the whole body. I am grateful for any and all research done in these areas. I am not a fan of big pharm and we have tried many challenging diets and supplement protocols to try to get to the root of my daughters problems without luck. She is of course, 100% gluten-free, and that is relatively easy for her but it is not relieving all of her auto immune issues. I cannot even find traditional docs that have a clue in treating auto immune. Any kind of research and testing that sheds some light in this area is a step forward.

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    Celiac.com 07/25/2016 - Celiac disease is one of the most common immune-mediated diseases. Often, a gluten-free diet does not fully control celiac symptoms and disease activity.
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    There are many reports in such journals connecting brain and neurological ailments with gluten, so it is not much of a stretch, on that basis alone, to suspect that stuttering may be a symptom of the gluten syndrome. Rodney Ford has even characterized celiac disease as an ailment that may begin through gluten-induced neurological damage (13) and Marios Hadjivassiliou and his group of neurologists and neurological investigators have devoted considerable time and effort to research that reveals gluten as an important factor in a majority of neurological diseases of unknown origin (14) which, as I have pointed out previously, includes most neurological ailments.
    My own experience with stuttering is limited. I stuttered as a child when I became nervous, upset, or self-conscious. Although I have been gluten free for many years, I haven’t noticed any impact on my inclination to stutter when upset. I don’t know if they are related, but I have also had challenges with speaking when distressed and I have noticed a substantial improvement in this area since removing gluten from my diet. Nonetheless, I have long wondered if there is a connection between gluten consumption and stuttering. Having done the research for this article, I would now encourage stutterers to try a gluten free diet for six months to see if it will reduce or eliminate their stutter. Meanwhile, I hope that some investigator out there will research this matter, publish her findings, and start the ball rolling toward getting some definitive answers to this question.
    Sources:
    1. Toft M, Dietrichs E. Aggravated stuttering following subthalamic deep brain stimulation in Parkinson’s disease--two cases. BMC Neurol. 2011 Apr 8;11:44.
    2. Tani T, Sakai Y. Stuttering after right cerebellar infarction: a case study. J Fluency Disord. 2010 Jun;35(2):141-5. Epub 2010 Mar 15.
    3. Lundgren K, Helm-Estabrooks N, Klein R. Stuttering Following Acquired Brain Damage: A Review of the Literature. J Neurolinguistics. 2010 Sep 1;23(5):447-454.
    4. Jäncke L, Hänggi J, Steinmetz H. Morphological brain differences between adult stutterers and non-stutterers. BMC Neurol. 2004 Dec 10;4(1):23.
    5. Kell CA, Neumann K, von Kriegstein K, Posenenske C, von Gudenberg AW, Euler H, Giraud AL. How the brain repairs stuttering. Brain. 2009 Oct;132(Pt 10):2747-60. Epub 2009 Aug 26.
    6. Galantucci S, Tartaglia MC, Wilson SM, Henry ML, Filippi M, Agosta F, Dronkers NF, Henry RG, Ogar JM, Miller BL, Gorno-Tempini ML. White matter damage in primary progressive aphasias: a diffusion tensor tractography study. Brain. 2011 Jun 11.
    7. Lundgren K, Helm-Estabrooks N, Klein R. Stuttering Following Acquired Brain Damage: A Review of the Literature. J Neurolinguistics. 2010 Sep 1;23(5):447-454.
    8. [No authors listed] Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Case 43-1988. A 52-year-old man with persistent watery diarrhea and aphasia. N Engl J Med. 1988 Oct 27;319(17):1139-48
    9. Molteni N, Bardella MT, Baldassarri AR, Bianchi PA. Celiac disease associated with epilepsy and intracranial calcifications: report of two patients. Am J Gastroenterol. 1988 Sep;83(9):992-4.
    10. http://ezinearticles.com/?Food-Allergy-and-Stuttering-Link&id=1235725 
    11. http://www.craig.copperleife.com/health/stuttering_allergies.htm 
    12. https://www.celiac.com/forums/topic/73362-any-help-is-appreciated/
    13. Ford RP. The gluten syndrome: a neurological disease. Med Hypotheses. 2009 Sep;73(3):438-40. Epub 2009 Apr 29.
    14. Hadjivassiliou M, Gibson A, Davies-Jones GA, Lobo AJ, Stephenson TJ, Milford-Ward A. Does cryptic gluten sensitivity play a part in neurological illness? Lancet. 1996 Feb 10;347(8998):369-71.

    Jefferson Adams
    Celiac.com 06/14/2018 - Refractory celiac disease type II (RCDII) is a rare complication of celiac disease that has high death rates. To diagnose RCDII, doctors identify a clonal population of phenotypically aberrant intraepithelial lymphocytes (IELs). 
    However, researchers really don’t have much data regarding the frequency and significance of clonal T cell receptor (TCR) gene rearrangements (TCR-GRs) in small bowel (SB) biopsies of patients without RCDII. Such data could provide useful comparison information for patients with RCDII, among other things.
    To that end, a research team recently set out to try to get some information about the frequency and importance of clonal T cell receptor (TCR) gene rearrangements (TCR-GRs) in small bowel (SB) biopsies of patients without RCDII. The research team included Shafinaz Hussein, Tatyana Gindin, Stephen M Lagana, Carolina Arguelles-Grande, Suneeta Krishnareddy, Bachir Alobeid, Suzanne K Lewis, Mahesh M Mansukhani, Peter H R Green, and Govind Bhagat.
    They are variously affiliated with the Department of Pathology and Cell Biology, and the Department of Medicine at the Celiac Disease Center, New York Presbyterian Hospital/Columbia University Medical Center, New York, USA. Their team analyzed results of TCR-GR analyses performed on SB biopsies at our institution over a 3-year period, which were obtained from eight active celiac disease, 172 celiac disease on gluten-free diet, 33 RCDI, and three RCDII patients and 14 patients without celiac disease. 
    Clonal TCR-GRs are not infrequent in cases lacking features of RCDII, while PCPs are frequent in all disease phases. TCR-GR results should be assessed in conjunction with immunophenotypic, histological and clinical findings for appropriate diagnosis and classification of RCD.
    The team divided the TCR-GR patterns into clonal, polyclonal and prominent clonal peaks (PCPs), and correlated these patterns with clinical and pathological features. In all, they detected clonal TCR-GR products in biopsies from 67% of patients with RCDII, 17% of patients with RCDI and 6% of patients with gluten-free diet. They found PCPs in all disease phases, but saw no significant difference in the TCR-GR patterns between the non-RCDII disease categories (p=0.39). 
    They also noted a higher frequency of surface CD3(−) IELs in cases with clonal TCR-GR, but the PCP pattern showed no associations with any clinical or pathological feature. 
    Repeat biopsy showed that the clonal or PCP pattern persisted for up to 2 years with no evidence of RCDII. The study indicates that better understanding of clonal T cell receptor gene rearrangements may help researchers improve refractory celiac diagnosis. 
    Source:
    Journal of Clinical Pathologyhttp://dx.doi.org/10.1136/jclinpath-2018-205023

    Jefferson Adams
    Celiac.com 06/13/2018 - There have been numerous reports that olmesartan, aka Benicar, seems to trigger sprue‐like enteropathy in many patients, but so far, studies have produced mixed results, and there really hasn’t been a rigorous study of the issue. A team of researchers recently set out to assess whether olmesartan is associated with a higher rate of enteropathy compared with other angiotensin II receptor blockers (ARBs).
    The research team included Y.‐H. Dong; Y. Jin; TN Tsacogianis; M He; PH Hsieh; and JJ Gagne. They are variously affiliated with the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School in Boston, MA, USA; the Faculty of Pharmacy, School of Pharmaceutical Science at National Yang‐Ming University in Taipei, Taiwan; and the Department of Hepato‐Gastroenterology, Chi Mei Medical Center in Tainan, Taiwan.
    To get solid data on the issue, the team conducted a cohort study among ARB initiators in 5 US claims databases covering numerous health insurers. They used Cox regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for enteropathy‐related outcomes, including celiac disease, malabsorption, concomitant diagnoses of diarrhea and weight loss, and non‐infectious enteropathy. In all, they found nearly two million eligible patients. 
    They then assessed those patients and compared the results for olmesartan initiators to initiators of other ARBs after propensity score (PS) matching. They found unadjusted incidence rates of 0.82, 1.41, 1.66 and 29.20 per 1,000 person‐years for celiac disease, malabsorption, concomitant diagnoses of diarrhea and weight loss, and non‐infectious enteropathy respectively. 
    After PS matching comparing olmesartan to other ARBs, hazard ratios were 1.21 (95% CI, 1.05‐1.40), 1.00 (95% CI, 0.88‐1.13), 1.22 (95% CI, 1.10‐1.36) and 1.04 (95% CI, 1.01‐1.07) for each outcome. Patients aged 65 years and older showed greater hazard ratios for celiac disease, as did patients receiving treatment for more than 1 year, and patients receiving higher cumulative olmesartan doses.
    This is the first comprehensive multi‐database study to document a higher rate of enteropathy in olmesartan initiators as compared to initiators of other ARBs, though absolute rates were low for both groups.
    Source:
    Alimentary Pharmacology & Therapeutics